Chemical GMP Synthesis Facility

Chemical GMP Synthesis Facility

The Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing facility for small and large molecule therapeutics for clinical trials.The CGSF provides services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances (APIs) that meet Food and Drug Administration requirements. With its significant capabilities, the CGSF plays a key role in bridging basic science and translational medicine at City of Hope. It is a key component within the Developmental Cancer Therapeutics Program. The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and phase I/II clinical trials.

Facilities Overview
The CGSF provides internal and external investigators with a regulatory compliant, cost effective route to bringing promising therapeutics to the clinic.

cGMP Grade API Manufacturing
The manufacturing suites are designed specifically to accommodate gram to kilogram production of cGMP-grade small molecule, biopolymer (peptides, siRNA-aptamers, DNA-peptide hybrids) and nano material APIs in support of phase I and II clinical trials. Adherence to cGMP (current good manufacturing practices) is essential in ensuring the quality and integrity of manufactured APIs.

Integrated Quality Control
Our on-site quality control unit is committed to providing excellence in service for the testing and release of manufactured APIs with strict adherence to requirements set forth by the Food and Drug Administration.

Chemistry Support
The CGSF is under the direction of Christopher Lincoln, Ph.D. who leads a team of synthetic and analytical chemists in providing an array of services and support in bringing benchtop discoveries to the clinic. These include:

Route selection and optimization Process development and scale-up Synthesis of GLP API for toxicology Synthesis and characterization of metabolites, impurities and reference standards

Facilities Overview

The manufacturing facilities at the Chemical GMP Synthesis Facility are designed specifically to handle the synthesis of APIs for phase I and phase II clinical trials. The manufacturing rooms are organized into three isolated, independent suites. The organic synthesis labs are specifically equipped to handle multigram to kilogram (phase I) and multikilogram (phase II) small molecule projects. The RNA/oligonucleotide laboratory suite is designed to accommodate production of cGMP-grade biopolymers (siRNA-aptamers, DNA-peptide hybrids, peptides).

Phase I Laboratory
The Phase I suite is equipped with three 6-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500 milliliters to 20 liters. Purifications are carried out using an automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.

Phase II Laboratory
The Phase II suite is equipped with two 8-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 20 to 100 liters. Purifications are carried out on a Biotage Flash 150 system, allowing for quick and efficient isolation of intermediates and final products.

RNA/Oligo Laboratory
The RNA/oligo laboratory has the ability to be equipped with the necessary synthesizers and purification equipment suitable for API manufacturing. Drugs in this category will be synthesized as lyophilized powders and processed in our Packaging/Purification Room using a VirTis Genesis 25EL Pilot Lyophilizer.

Packaging/Purification Room
This room is dedicated to single product packaging prior to transfer of APIs for release testing and clinical use.

Stability/Storage Room
This room is equipped with Norlake ICH chambers, a Caron photostability chamber and controlled temperature storage (2-8ºC, -20ºC) for analysis of stability and bulk storage of API.

Manufacturing Overview

The cGMP production laboratories at the Chemical GMP Synthesis Facility are focused on providing researchers with services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances.

The design of the facility allows for three simultaneous processes to be performed, under cGMP in functionally isolated areas of the facility.

Our chemists specialize in the synthesis of complex small molecules and possess experience in both industrial and academic environments, with a broad range of synthetic capabilities and the knowledge of the latest technologies and techniques.

Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

Contract Services

The Chemical GMP Synthesis Facility can assist in the synthesis of intermediates by providing fully integrated GLP and GMP manufacturing services, while avoiding the high costs typically associated with commercial suppliers.

Internal expertise in:

Asymmetric Synthesis

Transition-metal Catalyzed Reactions

Low-temperature Reactions

Heterocyclic Chemistry

Synthetic processes that are designed to:

Optimize Yields

Decrease Cycle Times

Improve Process Scalability

GLP/GMP synthetic capabilities:

Manufacture of API raw materials and intermediates from gram to multikilogram scales

Manufacture of fine chemical raw materials and intermediates from gram to multikilogram scales

Synthesis of various compound classes

Reference compound synthesis

Purification to Food and Drug Administration standards

API manufacturing

Our chemists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With extensive experience and a solid scientific background, our team has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies in purification to deliver an optimized product.

Services include:

cGMP manufacturing for preclinical and clinical APIs (phase I/II)

Gram to multikilogram synthesis

Manufacturing of APIs using supplied protocols or through custom synthetic routes designed to suit your needs

Quality Control

Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

QC Analysis of Intermediates, Drug Substances (DS) and CoA Release:

Identity

1H-,13C-NMR

HRMS, MSn

UV-Vis spectroscopy

IR spectroscopy

Refractive index

Optical rotation

Melting point

Purity

Chemical purity

Related substances

Quality Tests

Heavy metals

Organic volatile impurities

Loss on drying

Residue on ignition

pKa determination

Raw materials release

Other Services:

Mass Spectrometry/NMR Spectrometry

Structural confirmation of API and intermediates

Structural determination of trace impurities

Release Testing for Oliogonucelotides/siRNA/Aptamers/Peptides

Pricing

Pricing is dependent on the nature of the project and will be determined based upon the scope of work. Please contact us for more information and a quote.

Why City of Hope?

City of Hope’s pioneering research has brought the world closer to cures for many life-threatening diseases, from cancer to diabetes.

Compassion drives our innovation. Every discovery we make and new treatment we develop gives patients the chance to live longer, better and more fully.

Comprehensive Cancer Center

In recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.

Chemical GMP Synthesis Facility Team

People

TeamMembers

http://forms.cityofhope.org/directorysearch/

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Chemical GMP Synthesis Facility

Chemical GMP Synthesis Facility

The Chemical GMP Synthesis Facility (CGSF) is a state-of-the-art manufacturing facility for small and large molecule therapeutics for clinical trials.The CGSF provides services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances (APIs) that meet Food and Drug Administration requirements. With its significant capabilities, the CGSF plays a key role in bridging basic science and translational medicine at City of Hope. It is a key component within the Developmental Cancer Therapeutics Program. The facility is designed specifically to produce quantities of API on scales suitable for use in preclinical toxicology studies and phase I/II clinical trials.

Facilities Overview
The CGSF provides internal and external investigators with a regulatory compliant, cost effective route to bringing promising therapeutics to the clinic.

cGMP Grade API Manufacturing
The manufacturing suites are designed specifically to accommodate gram to kilogram production of cGMP-grade small molecule, biopolymer (peptides, siRNA-aptamers, DNA-peptide hybrids) and nano material APIs in support of phase I and II clinical trials. Adherence to cGMP (current good manufacturing practices) is essential in ensuring the quality and integrity of manufactured APIs.

Integrated Quality Control
Our on-site quality control unit is committed to providing excellence in service for the testing and release of manufactured APIs with strict adherence to requirements set forth by the Food and Drug Administration.

Chemistry Support
The CGSF is under the direction of Christopher Lincoln, Ph.D. who leads a team of synthetic and analytical chemists in providing an array of services and support in bringing benchtop discoveries to the clinic. These include:

Route selection and optimization Process development and scale-up Synthesis of GLP API for toxicology Synthesis and characterization of metabolites, impurities and reference standards

Facilities

Facilities Overview

The manufacturing facilities at the Chemical GMP Synthesis Facility are designed specifically to handle the synthesis of APIs for phase I and phase II clinical trials. The manufacturing rooms are organized into three isolated, independent suites. The organic synthesis labs are specifically equipped to handle multigram to kilogram (phase I) and multikilogram (phase II) small molecule projects. The RNA/oligonucleotide laboratory suite is designed to accommodate production of cGMP-grade biopolymers (siRNA-aptamers, DNA-peptide hybrids, peptides).

Phase I Laboratory
The Phase I suite is equipped with three 6-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 500 milliliters to 20 liters. Purifications are carried out using an automated Teledyne Isco Torrent purification system, allowing for quick and efficient isolation of intermediates and final products.

Phase II Laboratory
The Phase II suite is equipped with two 8-foot walk-in fume hoods. Reactions are carried out in dedicated Chemglass jacketed glass reactors, with capacities from 20 to 100 liters. Purifications are carried out on a Biotage Flash 150 system, allowing for quick and efficient isolation of intermediates and final products.

RNA/Oligo Laboratory
The RNA/oligo laboratory has the ability to be equipped with the necessary synthesizers and purification equipment suitable for API manufacturing. Drugs in this category will be synthesized as lyophilized powders and processed in our Packaging/Purification Room using a VirTis Genesis 25EL Pilot Lyophilizer.

Packaging/Purification Room
This room is dedicated to single product packaging prior to transfer of APIs for release testing and clinical use.

Stability/Storage Room
This room is equipped with Norlake ICH chambers, a Caron photostability chamber and controlled temperature storage (2-8ºC, -20ºC) for analysis of stability and bulk storage of API.

Manufacturing

Manufacturing Overview

The cGMP production laboratories at the Chemical GMP Synthesis Facility are focused on providing researchers with services for drug discovery, process research, development and early clinical manufacturing of pharmaceutical drug substances.

The design of the facility allows for three simultaneous processes to be performed, under cGMP in functionally isolated areas of the facility.

Our chemists specialize in the synthesis of complex small molecules and possess experience in both industrial and academic environments, with a broad range of synthetic capabilities and the knowledge of the latest technologies and techniques.

Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

Contract Services

Contract Services

The Chemical GMP Synthesis Facility can assist in the synthesis of intermediates by providing fully integrated GLP and GMP manufacturing services, while avoiding the high costs typically associated with commercial suppliers.

Internal expertise in:

Asymmetric Synthesis

Transition-metal Catalyzed Reactions

Low-temperature Reactions

Heterocyclic Chemistry

Synthetic processes that are designed to:

Optimize Yields

Decrease Cycle Times

Improve Process Scalability

GLP/GMP synthetic capabilities:

Manufacture of API raw materials and intermediates from gram to multikilogram scales

Manufacture of fine chemical raw materials and intermediates from gram to multikilogram scales

Synthesis of various compound classes

Reference compound synthesis

Purification to Food and Drug Administration standards

API manufacturing

Our chemists specialize in complex organic synthesis and possess experience in both industrial and academic environments. With extensive experience and a solid scientific background, our team has a broad range of synthetic organic chemistry capabilities, along with the knowledge of the latest techniques and technologies in purification to deliver an optimized product.

Services include:

cGMP manufacturing for preclinical and clinical APIs (phase I/II)

Gram to multikilogram synthesis

Manufacturing of APIs using supplied protocols or through custom synthetic routes designed to suit your needs

Quality Control

Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

QC Analysis of Intermediates, Drug Substances (DS) and CoA Release:

Identity

1H-,13C-NMR

HRMS, MSn

UV-Vis spectroscopy

IR spectroscopy

Refractive index

Optical rotation

Melting point

Purity

Chemical purity

Related substances

Quality Tests

Heavy metals

Organic volatile impurities

Loss on drying

Residue on ignition

pKa determination

Raw materials release

Other Services:

Mass Spectrometry/NMR Spectrometry

Structural confirmation of API and intermediates

Structural determination of trace impurities

Release Testing for Oliogonucelotides/siRNA/Aptamers/Peptides

Pricing

Pricing

Pricing is dependent on the nature of the project and will be determined based upon the scope of work. Please contact us for more information and a quote.

Why City of Hope?

City of Hope’s pioneering research has brought the world closer to cures for many life-threatening diseases, from cancer to diabetes.

Compassion drives our innovation. Every discovery we make and new treatment we develop gives patients the chance to live longer, better and more fully.

Comprehensive Cancer Center

In recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.

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